Treatment Strategy of Pancreatic Radiolucent Stone

NCT04628273 | Completed

• 1 other identifier: Large PRS
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• rate of pain relief

  Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score \> 10 after a decrease of \> 50%)

  after treatment to 2020-01-30

Secondary Outcomes (2)

• rate of stone clearance

  during ERCP procedure

• score of life quality

  after treatment to 2020-01-30

Study Arms (2)

radiolucent stone group

Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

radiopaque stone group

Procedure: encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

Interventions

encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy PROCEDURE

radiolucent stone group; radiopaque stone group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CP patients with pancreatic radiolucent stones large than 5mm from March 2011 to December 2018 admitted to Changhai Hospital were included in this study. Patients with pancreatic radiopaque stones large than 5mm were matched as the control group, with a ratio of 1:2 according to admission time. CP was diagnosed primarily based on the Asia-Pacific consensus. Pancreatic radiopaque stone was diagnosed by CT scan while radiolucent stone by MRI or MRCP.

You may qualify if:

• Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm

You may not qualify if:

• Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis

Sponsors & Collaborators

• Changhai Hospital: lead

Related Publications (5)

• Tandan M, Reddy DN, Santosh D, Vinod K, Ramchandani M, Rajesh G, Rama K, Lakhtakia S, Banerjee R, Pratap N, Venkat Rao G. Extracorporeal shock wave lithotripsy and endotherapy for pancreatic calculi-a large single center experience. Indian J Gastroenterol. 2010 Jul;29(4):143-8. doi: 10.1007/s12664-010-0035-y. Epub 2010 Aug 18.

  PMID: 20717860 BACKGROUND

• Neuhaus H. Fragmentation of pancreatic stones by extracorporeal shock wave lithotripsy. Endoscopy. 1991 May;23(3):161-5. doi: 10.1055/s-2007-1010647. No abstract available.

  PMID: 1860446 BACKGROUND

• Sauerbruch T, Holl J, Sackmann M, Paumgartner G. Extracorporeal lithotripsy of pancreatic stones in patients with chronic pancreatitis and pain: a prospective follow up study. Gut. 1992 Jul;33(7):969-72. doi: 10.1136/gut.33.7.969.

  PMID: 1644340 BACKGROUND

• Delhaye M, Arvanitakis M, Verset G, Cremer M, Deviere J. Long-term clinical outcome after endoscopic pancreatic ductal drainage for patients with painful chronic pancreatitis. Clin Gastroenterol Hepatol. 2004 Dec;2(12):1096-106. doi: 10.1016/s1542-3565(04)00544-0.

  PMID: 15625655 BACKGROUND

• Maydeo A, Bhandari S, Bapat M. Endoscopic balloon sphincteroplasty for extraction of large radiolucent pancreatic duct stones (with videos). Gastrointest Endosc. 2009 Oct;70(4):798-802. doi: 10.1016/j.gie.2009.05.004.

  PMID: 19788986 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology，Changhai Hospital；Academician of Chinese Academy of Engineering

Study Record Dates

• First Submitted: November 7, 2020
• First Posted: November 13, 2020
• Study Start: March 1, 2011
• Primary Completion: December 30, 2018
• Study Completion: January 30, 2020
• Last Updated: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share